Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog… — Class II medical device recall Z-0159-2015
Terminated recall by Terumo Cardiovascular Systems Corp, reported 2014-11-12, distributed nationwide. Defect in the luer connector can compromise the seal on the female side of the connector and the compromised s
| Recall number | Z-0159-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corp, Ashland, MA, United States |
| Recall initiated | 2011-03-01 |
| Classified | 2014-10-31 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, HK, KR, TH |
| Reason classes | packaging |
| Lot numbers | ML07, ML20, MM18, MM25, MN08, MN15, MN22, MN29, MNO1, MP06, MP13 |
| Model numbers | 6XXXX, 7XXXX |
Product
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
Reason for recall
Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0159-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.